The Effect of Lavender Aromatherapy on Sleep in Hospitalized Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Change in sleep duration from Baseline to Day 3 and day 4
研究概览
简要总结
This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients
详细描述
Hospitalized patients on a medical unit will be randomly assigned to one of three groups of 36 patients: Intervention (Lavender oil), Placebo Intervention (Grapeseed Oil), or Control (Standard of Care). Following a determination of meeting inclusion criteria on admission and completing informed consent, subjects will be randomized to one of three groups on admission. This is a 4 day study with pre- intervention (baseline) sleep data on quality and duration of sleep using the Verrans & Halpern- Snyder Sleep Scale collected on Day 2, following admission day.
For the intervention, indirect aromatherapy, a 2x2 gauze with 2 drops of either oil (lavender or grapeseed is pinned it to the subjects' nightgown (right scapula area) for two sequential nights (Time 1 and Time 2) (Day 2 and 3) and removed in the morning after 10 hours . Sleep Quality and Duration are then measured in the morning, Time 1 and Time 2, (Day 3 and Day 4) by the Verran & Snyder-Halpern Sleep Scale analogue. The control group receives standard of care in the evenings and the same data as the intervention groups are collected for sleep quality and duration, pre-intervention and Time 1 and Time 2 ..
The differences in the scores for sleep quality and duration will be compared from pre-intervention to Time 1 and Time 2 for each group .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Cognitive impairment .Allergy to lavender or grapeseed oil
- •.Any condition that has been reported to affect the sense of smell
- •Newly prescribed sleep medications (last two weeks prior to admission) or those causing sleepiness
- •Pregnancy
- •Currently using lavender therapy (aroma, massage, etc.).
- •A smoker of any kind (tobacco, electronic cigarettes) .
- •History of migraine headaches.
- •Asthma, Bronchitis, or any airway disease.
结局指标
主要结局
Change in sleep duration from Baseline to Day 3 and day 4
时间窗: Baseline, Day 3, Day 4
Measured by an increase in the mean scores Verans and Snyder-Halpern Sleep Scale (0-100) by 10 or greater
Change in sleep quality from Baseline to Day 3 and Day 4
时间窗: Baseline Day 3, Day 4
Measured by an increase in mean scores on the the Verans and Snyder-Halpern Sleep Scale of 10 or greater
次要结局
未报告次要终点